MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,07 report with the FDA on 2013-10-21 for SUR-FIT NATURA 2 PC-POST OP DRAINABLE KIT 416930 manufactured by Convatec Dominican Republic, Inc..
[3901260]
It is reported that during installation of the loop rod in the operating room, the nozzle of the loop rod fell off. As a result, the articulation of the loop rod withdrew during the passage into the colon of the muscular wall, supported by a lever mechanism. It is further reported that the small removable part is back in the abdomen.
Patient Sequence No: 1, Text Type: D, B5
[11445744]
Based on the info provided this event is deemed serious injury. The following clinical consequences for the pt is reported as follows: very inflammatory and edematous colon and that the operation was extended for more than 15 minutes. Further info reports that the period between the date on which the sales representative became aware of the complaint and the date of notification to the (b)(4) resulting in pending an appointment with the surgeon to have the necessary info for this report, and the completed form by the complainant. No additional pt/event details have been provided to date. A return sample for evaluation is not expected. Should additional info becomes available a follow-up report will be submitted. Reported to the fda on (b)(4) 2013. Note: the actual date of event is unk, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9618003-2013-00042 |
| MDR Report Key | 3429916 |
| Report Source | 01,04,05,07 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-09-10 |
| Date of Event | 2013-09-10 |
| Date Mfgr Received | 2013-09-10 |
| Date Added to Maude | 2013-10-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOC. DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUR-FIT NATURA 2 PC-POST OP DRAINABLE KIT |
| Generic Name | ROD, COLOSTOMY |
| Product Code | EZP |
| Date Received | 2013-10-21 |
| Model Number | 416930 |
| Catalog Number | 416930 |
| Lot Number | CNO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC, INC. |
| Manufacturer Address | CARRETERA SANCHEZ, KM. 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA, SAN CRISTOBAL 33102 DR 33102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-21 |